carbamates has been researched along with Sleep Apnea, Obstructive in 20 studies
Sleep Apnea, Obstructive: A disorder characterized by recurrent apneas during sleep despite persistent respiratory efforts. It is due to upper airway obstruction. The respiratory pauses may induce HYPERCAPNIA or HYPOXIA. Cardiac arrhythmias and elevation of systemic and pulmonary arterial pressures may occur. Frequent partial arousals occur throughout sleep, resulting in relative SLEEP DEPRIVATION and daytime tiredness. Associated conditions include OBESITY; ACROMEGALY; MYXEDEMA; micrognathia; MYOTONIC DYSTROPHY; adenotonsilar dystrophy; and NEUROMUSCULAR DISEASES. (From Adams et al., Principles of Neurology, 6th ed, p395)
| Excerpt | Relevance | Reference |
|---|---|---|
| "The results of this indirect treatment comparison show 12 weeks of treatment with solriamfetol, modafinil, and armodafinil resulted in varying levels of improvement on the ESS, MWT20, and CGI-C and similar safety risks in participants with excessive daytime sleepiness associated with obstructive sleep apnea." | 9.12 | Indirect treatment comparison of solriamfetol, modafinil, and armodafinil for excessive daytime sleepiness in obstructive sleep apnea. ( Bron, M; Bujanover, S; Kratochvil, D; Lucas, E; Menno, D; Patel, D; Ronnebaum, S; Stepnowsky, C, 2021) |
| "The results of this indirect treatment comparison show 12 weeks of treatment with solriamfetol, modafinil, and armodafinil resulted in varying levels of improvement on the ESS, MWT20, and CGI-C and similar safety risks in participants with excessive daytime sleepiness associated with obstructive sleep apnea." | 5.12 | Indirect treatment comparison of solriamfetol, modafinil, and armodafinil for excessive daytime sleepiness in obstructive sleep apnea. ( Bron, M; Bujanover, S; Kratochvil, D; Lucas, E; Menno, D; Patel, D; Ronnebaum, S; Stepnowsky, C, 2021) |
| " Pitolisant, a novel histamine-3 receptor antagonist/inverse agonist, gained approval for the treatment of excessive daytime sleepiness in adults with narcolepsy as well as obstructive sleep apnea." | 5.05 | New pharmacologic agents for insomnia and hypersomnia. ( Earl, DC; Van Tyle, KM, 2020) |
| "This post hoc analysis characterized the weekly incidence and overall duration of common early-onset, treatment-emergent adverse events (TEAEs) during solriamfetol treatment." | 3.11 | Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. ( Bujanover, S; Dauvilliers, Y; Gotfried, M; Malhotra, A; Rosenberg, R; Scheckner, B; Schweitzer, PK; Thorpy, MJ; Zammit, G, 2022) |
| "Excessive daytime sleepiness (EDS) is a common condition in which an individual is unable to stay awake during periods when they typically would be awake." | 3.01 | Solriamfetol: A Review in Excessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnoea. ( Hoy, SM, 2023) |
| " Common treatment-emergent adverse events (TEAEs) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4." | 2.94 | Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. ( Ahmed, M; Baladi, M; Chandler, P; Foldvary-Schaefer, N; Hedner, J; Lee, L; Malhotra, A; Mayer, G; Pepin, JL; Sarmiento, K; Schwab, R; Shapiro, C; Strollo, PJ, 2020) |
| "Excessive sleepiness (ES) is a common symptom of OSA, which often persists despite primary OSA therapy." | 2.90 | Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. ( Black, J; Carter, LP; Chen, D; Collop, N; Hedner, J; Lee, L; Lorch, DG; Lu, Y; Pépin, JL; Redline, S; Strollo, PJ, 2019) |
| " The proportion of patients with at least one adverse event was significantly increased in solriamfetol group (RR = 1." | 2.72 | Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials. ( Chen, G; Gao, H; Li, X; Wang, J; Wang, T; Xu, X; Xu, Z; Yang, S, 2021) |
| " The primary outcomes were mean difference in the maintenance of wakefulness test (MWT), Epworth sleepiness scale (ESS) score, and risk ratio of adverse events." | 2.66 | Efficacy and safety of solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: a systematic review and meta-analysis of clinical trials. ( Jha, D; K C, B; Ray, BK; Singh, R; Subedi, R; Thakur, RK, 2020) |
| " The objective of this study was to describe dosing and titration strategies used when initiating solriamfetol and to assess whether and how patient factors affected these strategies." | 1.72 | Solriamfetol Titration and AdministRaTion (START) in Patients with Obstructive Sleep Apnea: A Retrospective Chart Review and Hypothetical Patient Scenario. ( Baldys, B; Chen, A; Foley, C; Hyman, D; Ito, D; Parks, GS; Singh, H; Thorpy, MJ, 2022) |
| "Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale (ESS) at baseline and at week 12." | 1.62 | Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. ( Baladi, M; Bron, M; Rosenberg, R, 2021) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 2 (10.00) | 24.3611 |
| 2020's | 18 (90.00) | 2.80 |
| Authors | Studies |
|---|---|
| Weaver, TE | 2 |
| Pepin, JL | 3 |
| Schwab, R | 2 |
| Shapiro, C | 2 |
| Hedner, J | 3 |
| Ahmed, M | 2 |
| Foldvary-Schaefer, N | 2 |
| Strollo, PJ | 3 |
| Mayer, G | 4 |
| Sarmiento, K | 2 |
| Baladi, M | 5 |
| Bron, M | 4 |
| Chandler, P | 4 |
| Lee, L | 5 |
| Malhotra, A | 7 |
| Vinckenbosch, F | 1 |
| Asin, J | 1 |
| de Vries, N | 1 |
| Vonk, PE | 1 |
| Donjacour, CEHM | 1 |
| Lammers, GJ | 1 |
| Overeem, S | 1 |
| Janssen, H | 1 |
| Wang, G | 1 |
| Chen, D | 3 |
| Carter, LP | 3 |
| Zhou, K | 1 |
| Vermeeren, A | 1 |
| Ramaekers, JG | 1 |
| Singh, H | 1 |
| Hyman, D | 1 |
| Parks, GS | 1 |
| Chen, A | 1 |
| Foley, C | 1 |
| Baldys, B | 1 |
| Ito, D | 1 |
| Thorpy, MJ | 2 |
| Krystal, AD | 1 |
| Benca, RM | 1 |
| Rosenberg, R | 6 |
| Schweitzer, PK | 5 |
| Babson, K | 1 |
| Bujanover, S | 3 |
| Strohl, KP | 4 |
| Hoy, SM | 1 |
| Javaheri, S | 2 |
| Powell, J | 1 |
| Piszczatoski, C | 1 |
| Garland, S | 1 |
| Earl, DC | 1 |
| Van Tyle, KM | 1 |
| Subedi, R | 1 |
| Singh, R | 1 |
| Thakur, RK | 1 |
| K C, B | 1 |
| Jha, D | 1 |
| Ray, BK | 1 |
| Menno, DM | 1 |
| Crosby, RD | 1 |
| Morris, S | 1 |
| Mathias, SD | 1 |
| Wang, J | 1 |
| Yang, S | 1 |
| Li, X | 1 |
| Wang, T | 1 |
| Xu, Z | 1 |
| Xu, X | 1 |
| Gao, H | 1 |
| Chen, G | 1 |
| Zammit, GK | 2 |
| Gotfried, M | 3 |
| Dauvilliers, Y | 1 |
| Zammit, G | 1 |
| Scheckner, B | 1 |
| Ronnebaum, S | 1 |
| Patel, D | 1 |
| Menno, D | 1 |
| Kratochvil, D | 1 |
| Lucas, E | 1 |
| Stepnowsky, C | 1 |
| Krief, S | 1 |
| Berrebi-Bertrand, I | 1 |
| Nagmar, I | 1 |
| Giret, M | 1 |
| Belliard, S | 1 |
| Perrin, D | 1 |
| Uguen, M | 1 |
| Robert, P | 1 |
| Lecomte, JM | 1 |
| Schwartz, JC | 1 |
| Finance, O | 1 |
| Ligneau, X | 1 |
| Collop, N | 1 |
| Lorch, DG | 1 |
| Lu, Y | 2 |
| Black, J | 2 |
| Redline, S | 1 |
| Wang, H | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea[NCT02348632] | Phase 3 | 645 participants (Actual) | Interventional | 2015-05-31 | Completed | ||
| A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive [NCT02348606] | Phase 3 | 476 participants (Actual) | Interventional | 2015-05-31 | Completed | ||
| A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy[NCT02348593] | Phase 3 | 239 participants (Actual) | Interventional | 2015-05-31 | Completed | ||
| A Double-Blind, Randomized, Placebo-Controlled, Single-Center, Flexible Titration Study Evaluating the Efficacy of Solriamfetol in Treating Fatigue and Cognitive Symptoms in Adults Aged 18-65 Years With a Diagnosis of Myalgic Encephalomyelitis/Chronic Fat[NCT04622293] | Phase 4 | 44 participants (Anticipated) | Interventional | 2021-04-27 | Recruiting | ||
| A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep A[NCT02348619] | Phase 3 | 174 participants (Actual) | Interventional | 2015-05-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period." (NCT02348632)
Timeframe: Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)
| Intervention | points on a scale (Least Squares Mean) |
|---|---|
| JZP-110 | 1.6 |
| Placebo | 5.3 |
Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. (NCT02348632)
Timeframe: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
| Intervention | percentage of subjects (Number) |
|---|---|
| JZP-110 | 28.7 |
| Placebo | 63.8 |
Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. (NCT02348632)
Timeframe: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
| Intervention | percentage of subjects (Number) |
|---|---|
| JZP-110 | 28.2 |
| Placebo | 64.5 |
"Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline." (NCT02348606)
Timeframe: Baseline to Week 12
| Intervention | points on a scale (Least Squares Mean) |
|---|---|
| 37.5 mg of JZP-110 | -5.1 |
| 75 mg of JZP-110 | -5.0 |
| 150 mg of JZP-110 | -7.7 |
| 300 mg of JZP-110 | -7.9 |
| Placebo | -3.3 |
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. (NCT02348606)
Timeframe: Baseline to Week 12
| Intervention | minutes (Least Squares Mean) |
|---|---|
| 37.5 mg of JZP-110 | 4.74 |
| 75 mg of JZP-110 | 9.08 |
| 150 mg of JZP-110 | 10.96 |
| 300 mg of JZP-110 | 12.99 |
| Placebo | 0.21 |
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4. (NCT02348606)
Timeframe: Baseline to Week 4
| Intervention | minutes (Least Squares Mean) |
|---|---|
| 37.5 mg of JZP-110 | 4.53 |
| 75 mg of JZP-110 | 7.20 |
| 150 mg of JZP-110 | 11.69 |
| 300 mg of JZP-110 | 13.77 |
| Placebo | 1.24 |
Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse. (NCT02348606)
Timeframe: Week 12
| Intervention | percentage of subjects (Number) |
|---|---|
| 37.5 mg of JZP-110 | 58.9 |
| 75 mg of JZP-110 | 70.7 |
| 150 mg of JZP-110 | 90.5 |
| 300 mg of JZP-110 | 88.7 |
| Placebo | 49.1 |
"Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.~This is the key secondary endpoint." (NCT02348606)
Timeframe: 12 Weeks
| Intervention | percentage of subjects (Number) |
|---|---|
| 37.5 mg of JZP-110 | 55.4 |
| 75 mg of JZP-110 | 72.4 |
| 150 mg of JZP-110 | 89.7 |
| 300 mg of JZP-110 | 88.7 |
| Placebo | 49.1 |
"Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline." (NCT02348606)
Timeframe: Baseline to Weeks 1, 4, and 8
| Intervention | points on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Week 1 | Week 4 | Week 8 | |
| 150 mg of JZP-110 | -5.5 | -6.1 | -6.9 |
| 300 mg of JZP-110 | -6.6 | -6.6 | -7.7 |
| 37.5 mg of JZP-110 | -4.5 | -4.7 | -4.7 |
| 75 mg of JZP-110 | -4.4 | -4.8 | -6.3 |
| Placebo | -2.6 | -2.9 | -3.8 |
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12. (NCT02348606)
Timeframe: Baseline and Week 12
| Intervention | minutes (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Trial 1 | Trial 2 | Trial 3 | Trial 4 | Trial 5 | |
| 150 mg of JZP-110 | 10.87 | 11.91 | 11.50 | 8.93 | 8.05 |
| 300 mg of JZP-110 | 12.48 | 14.94 | 10.90 | 11.94 | 7.59 |
| 37.5 mg of JZP-110 | 3.03 | 6.93 | 3.59 | 6.11 | 3.57 |
| 75 mg of JZP-110 | 5.77 | 9.47 | 11.32 | 9.04 | 7.75 |
| Placebo | -0.40 | -0.44 | 0.58 | 1.29 | 0.18 |
Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse. (NCT02348606)
Timeframe: Weeks 1, 4, and 8
| Intervention | percentage of subjects (Number) | ||
|---|---|---|---|
| Week 1 | Week 4 | Week 8 | |
| 150 mg of JZP-110 | 75.7 | 85.2 | 87.8 |
| 300 mg of JZP-110 | 82.6 | 81.7 | 87.8 |
| 37.5 mg of JZP-110 | 62.5 | 60.7 | 55.4 |
| 75 mg of JZP-110 | 60.3 | 77.6 | 74.1 |
| Placebo | 46.5 | 52.6 | 49.1 |
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse. (NCT02348606)
Timeframe: Weeks 1, 4, and 8
| Intervention | percentage of subjects (Number) | ||
|---|---|---|---|
| Week 1 | Week 4 | Week 8 | |
| 150 mg of JZP-110 | 78.3 | 84.5 | 88.8 |
| 300 mg of JZP-110 | 82.5 | 84.3 | 87.8 |
| 37.5 mg of JZP-110 | 58.9 | 60.7 | 57.1 |
| 75 mg of JZP-110 | 65.5 | 77.6 | 79.3 |
| Placebo | 47.4 | 53.5 | 57.0 |
"Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline." (NCT02348593)
Timeframe: Baseline to Week 12
| Intervention | points on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.6 |
| 75 mg of JZP-110 | -3.8 |
| 150 mg JZP-110 | -5.4 |
| 300 mg of JZP-110 | -6.4 |
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing. (NCT02348593)
Timeframe: Baseline to Week 12
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Placebo | 2.12 |
| 75 mg of JZP-110 | 4.74 |
| 150 mg JZP-110 | 9.77 |
| 300 mg of JZP-110 | 12.27 |
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 1 at week 12
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Placebo | -0.55 |
| 75 mg of JZP-110 | 3.27 |
| 150 mg JZP-110 | 9.87 |
| 300 mg of JZP-110 | 9.91 |
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 2 at week 12
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Placebo | 1.41 |
| 75 mg of JZP-110 | 5.70 |
| 150 mg JZP-110 | 9.46 |
| 300 mg of JZP-110 | 14.50 |
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 3 at week 12
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Placebo | 3.79 |
| 75 mg of JZP-110 | 6.35 |
| 150 mg JZP-110 | 11.31 |
| 300 mg of JZP-110 | 13.99 |
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 4 at week 12
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Placebo | 2.33 |
| 75 mg of JZP-110 | 3.77 |
| 150 mg JZP-110 | 9.77 |
| 300 mg of JZP-110 | 13.50 |
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 5 at week 12
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Placebo | 3.09 |
| 75 mg of JZP-110 | 3.92 |
| 150 mg JZP-110 | 9.25 |
| 300 mg of JZP-110 | 12.20 |
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from Baseline to Week 4. (NCT02348593)
Timeframe: Baseline to Week 4
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Placebo | 2.16 |
| 75 mg of JZP-110 | 4.67 |
| 150 mg JZP-110 | 9.15 |
| 300 mg of JZP-110 | 13.07 |
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse (NCT02348593)
Timeframe: Baseline to Week 12
| Intervention | percentage of subjects (Number) |
|---|---|
| Placebo | 39.7 |
| 75 mg of JZP-110 | 67.8 |
| 150 mg JZP-110 | 78.2 |
| 300 mg of JZP-110 | 84.7 |
Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities. (NCT02348619)
Timeframe: Week 4 to Week 6
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| JZP-110 | -0.15 |
| Placebo | -1.31 |
"Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from week 4 to week 6." (NCT02348619)
Timeframe: Week 4 to Week 6
| Intervention | points on a scale (Least Squares Mean) |
|---|---|
| JZP-110 | -0.1 |
| Placebo | 4.5 |
Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements. (NCT02348619)
Timeframe: Week 4 to Week 6
| Intervention | minutes (Least Squares Mean) |
|---|---|
| JZP-110 | -0.96 |
| Placebo | -12.11 |
Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse. (NCT02348619)
Timeframe: Week 4 to Week 6
| Intervention | percentage of subjects (Number) |
|---|---|
| JZP-110 | 22 |
| Placebo | 59 |
Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse. (NCT02348619)
Timeframe: Week 4 to Week 6
| Intervention | percentage of subjects (Number) |
|---|---|
| JZP-110 | 20 |
| Placebo | 50 |
7 reviews available for carbamates and Sleep Apnea, Obstructive
| Article | Year |
|---|---|
Solriamfetol: A Review in Excessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnoea.
Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Sleep Apnea, Obstructive | 2023 |
Update on Persistent Excessive Daytime Sleepiness in OSA.
Topics: Carbamates; Disorders of Excessive Somnolence; Humans; Modafinil; Phenylalanine; Piperidines; Sleep | 2020 |
Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea.
Topics: Carbamates; Clinical Trials as Topic; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenyla | 2020 |
New pharmacologic agents for insomnia and hypersomnia.
Topics: Azepines; Carbamates; Dementia; Disorders of Excessive Somnolence; GABA-A Receptor Agonists; Humans; | 2020 |
Efficacy and safety of solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: a systematic review and meta-analysis of clinical trials.
Topics: Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenylalanine; Sleep Apnea, Obstr | 2020 |
Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials.
Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenylalanine; Randomized | 2021 |
Indirect treatment comparison of solriamfetol, modafinil, and armodafinil for excessive daytime sleepiness in obstructive sleep apnea.
Topics: Benzhydryl Compounds; Carbamates; Disorders of Excessive Somnolence; Double-Blind Method; Humans; Mo | 2021 |
9 trials available for carbamates and Sleep Apnea, Obstructive
| Article | Year |
|---|---|
Effects of solriamfetol on on-the-road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea.
Topics: Carbamates; Disorders of Excessive Somnolence; Humans; Phenylalanine; Sleep Apnea, Obstructive | 2022 |
Solriamfetol treatment of excessive daytime sleepiness in participants with narcolepsy or obstructive sleep apnea with a history of depression.
Topics: Carbamates; Depression; Disorders of Excessive Somnolence; Double-Blind Method; Humans; Narcolepsy; | 2022 |
Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea.
Topics: Carbamates; Disorders of Excessive Somnolence; Double-Blind Method; Humans; Narcolepsy; Phenylalanin | 2020 |
Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy.
Topics: Carbamates; Continuous Positive Airway Pressure; Disorders of Excessive Somnolence; Humans; Phenylal | 2021 |
Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea.
Topics: Adolescent; Adult; Aged; Carbamates; Female; Humans; Male; Middle Aged; Narcolepsy; Phenylalanine; S | 2021 |
Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA: An Analysis of Subgroups Adherent or Nonadherent to OSA Treatment.
Topics: Adolescent; Adult; Aged; Carbamates; Disorders of Excessive Somnolence; Double-Blind Method; Female; | 2021 |
Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy.
Topics: Carbamates; Disorders of Excessive Somnolence; Humans; Incidence; Narcolepsy; Phenylalanine; Randomi | 2022 |
Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy.
Topics: Carbamates; Disorders of Excessive Somnolence; Humans; Incidence; Narcolepsy; Phenylalanine; Randomi | 2022 |
Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy.
Topics: Carbamates; Disorders of Excessive Somnolence; Humans; Incidence; Narcolepsy; Phenylalanine; Randomi | 2022 |
Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy.
Topics: Carbamates; Disorders of Excessive Somnolence; Humans; Incidence; Narcolepsy; Phenylalanine; Randomi | 2022 |
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Topics: Adult; Aged; Carbamates; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Mi | 2019 |
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Topics: Adult; Aged; Carbamates; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Mi | 2019 |
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Topics: Adult; Aged; Carbamates; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Mi | 2019 |
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Topics: Adult; Aged; Carbamates; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Mi | 2019 |
Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial.
Topics: Adult; Aged; Carbamates; Disorders of Excessive Somnolence; Dopamine Uptake Inhibitors; Double-Blind | 2019 |
4 other studies available for carbamates and Sleep Apnea, Obstructive
| Article | Year |
|---|---|
Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenylalanine; Quality of | 2021 |
Solriamfetol Titration and AdministRaTion (START) in Patients with Obstructive Sleep Apnea: A Retrospective Chart Review and Hypothetical Patient Scenario.
Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Female; Humans; Male; Middle Aged; Phenylalani | 2022 |
Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea.
Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenylalanine; Sleep Apnea | 2021 |
Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea.
Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenylalanine; Sleep Apnea | 2021 |
Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea.
Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenylalanine; Sleep Apnea | 2021 |
Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea.
Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenylalanine; Sleep Apnea | 2021 |
Pitolisant, a wake-promoting agent devoid of psychostimulant properties: Preclinical comparison with amphetamine, modafinil, and solriamfetol.
Topics: 3,4-Dihydroxyphenylacetic Acid; Adrenergic Uptake Inhibitors; Amphetamine; Animals; Carbamates; Corp | 2021 |